Future Opportunity: Clinical Research Start-up Project Manager

Описание

Future Opportunity: Start-up Project Manager

At Biomapas, we are continuously expanding our Clinical Trial projects, and this means we are always on the lookout for talented Start-up Project Manager to join our team. While we may not have an immediate opening, we are proactively seeking experienced Start-up Project Manager who see themselves as part of our growing team. If you are passionate about clinical research, project leadership, and working in an international environment, we invite you to submit your application today. We will get in touch when a suitable opportunity arises!

As a Start-up Project Manageryou will be responsible for leading and oversight deliverables for clinical trials start-up activities in accordance with ICH GCP, EU CTR requirements CTIS (Part I and Part II), and local countries level regulatory requirements where your expertise will shape operational efficiency.

You must submit your CV in the English language for consideration

Responsibilities:

• Projects SUPM oversight: manage oversight of start-up activities (starting from feasibility completed till sites’ activation) within assigned projects.
• CA and EC submissions management: oversee the preparation and submissions of clinical trial applications under EU CTR and other applicable country level regulatory requirements.
• Site start-up management: supervise sites documents collection for CA and EC submissions and for IP release /essential documents packages.
• Client management: acting as the primary point of contact to the Clients during start-up trials phase, developing trials SSU timelines and submission strategy in collaboration with the Clinical Project Manager and the Client.
• Cross-functional leadership: coordinate trial start-up activities in close cooperation with Clinical Operations, Regulatory Affairs, Contracts & Budgets, Vendor Management departments.
• Risk & Time management: develop and maintain SSU strategy and timelines as per committed to Clients’ deliverables. Timely identify potential bottlenecks or study start up processes, suggest and implement mitigations strategies.

Requirements

• Strong understanding oof EU CTR and CTIS submission process, proven experience of submissions done via CTIS (Part I and Part II).
• Proven experience being a Start-up PM, Start-up lead within CRO, managing multicounty studies.
• Strong knowledge of ICH-GCP, local regulatory frameworks, and clinical trial lifecycle
• Exceptional organizational, time-management and communication skills.
• Managing start-up activities in multicounty or global trials is a major plus.    
• Ability to work both independently and as a key trial team member.
• Experience managing start-up activities in Ukraine, Georgia, Kazakhstan Armenia, or similar emerging clinical research regions is a plus    
• English fluent, local languages proficiency is an advantage.

Benefits

• International team and environment
• Performance based annual bonus
• Remote Work, Workation & Flexibility
• Health & Wellbeing – wellness initiatives
• Professional growth and development in the Life science industry
• Team Culture – Team buildings, global meetings, and B Active events.
• Comprehensive Insurance - Personal accident, business trip coverage, and additional health insurance.